Individuals & Families
Small Businesses
Nonprofits
Employers
Employee Benefits Brokers
PEOs
Credit Unions
Membership Groups
Legal Information
Sign In
/
U.S. Code of Federal Regula...
/
Title 21-Food and Drugs
/
CHAPTER I—FOOD AND DRUG ADM...
/
PART 610—GENERAL BIOLOGICAL PRODUCTS STANDARDS
PART 610—GENERAL BIOLOGICAL PRODUCTS STANDARDS
§ 610.1 - Tests prior to release required for each lot.
§ 610.2 - Requests for samples and protocols; official release.
§ 610.9 - Equivalent methods and processes.
§ 610.10 - Potency.
§ 610.11-610.11a - Sterility.
§ 610.12 - Sterility.
§ 610.13 - Purity.
§ 610.14 - Identity.
§ 610.15 - Constituent materials.
§ 610.16 - Total solids in serums.
§ 610.17 - Permissible combinations.
§ 610.18 - Cultures.
§§ 610.20-610.21 - Test for Mycoplasma.
§ 610.30 - Test for Mycoplasma.
§ 610.39 - Definitions.
§ 610.40 - Test requirements.
§ 610.41 - Donor deferral.
§ 610.42 - Restrictions on use for further manufacture of medical devices.
§ 610.44 - Use of reference panels by manufacturers of test kits.
§ 610.46 - Human immunodeficiency virus (HIV) “lookback” requirements.
§ 610.47 - Hepatitis C virus (HCV) “lookback” requirements.
§ 610.48 - Date of manufacture for biological products.
§ 610.50 - Date of manufacture for biological products.
§ 610.53 - Dating periods for Whole Blood and blood components.
§ 610.60 - Container label.
§ 610.61 - Package label.
§ 610.62 - Proper name; package label; legible type.
§ 610.63 - Divided manufacturing responsibility to be shown.
§ 610.64 - Name and address of distributor.
§ 610.65 - Products for export.
§ 610.67 - Bar code label requirements.
§ 610.68 - Exceptions or alternatives to labeling requirements for biological products held by the Strategic National Stockpile.